Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017
Рет қаралды 23,525
Күн бұрынMaria Cecilia Tami and Balajee Shanmugam review the Chemistry, Manufacturing and Controls (CMC) portion of a drug intended for use under an investigational new drug application (IND). The review resides in the Office of New Drug Products (ONDP) and in the Office of Biotechnological Products (OBP). ONDP reviews small molecules while biologics are reviewed by OBP.
This session discusses the CMC information for small molecules and biologics required for an IND per 21 CFR 312.23, especially with reference to the drug substance (characterization, manufacturing, testing, and stability) and drug product (composition, manufacture, testing and stability), to support that the investigational drug is reasonably safe for use in a clinical trial. The presentation will also discuss case studies of CMC related clinical hold issues.
-------------------------
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming training and free continuing education credits: www.fda.gov/cd...
CDER SBIA 2017 Playlist: • 2017 CDER Small Busine...
LinkedIn: / cder-small-business-an...
Training resources: www.fda.gov/cd...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
U.S. Food and Drug Administration
Рет қаралды 16 М.
U.S. Food and Drug Administration
Рет қаралды 28 М.
Jaidarman OFFICIAL / JCI
Рет қаралды 188 М.
U.S. Food and Drug Administration
Рет қаралды 16 М.
U.S. Food and Drug Administration
Рет қаралды 10 М.
U.S. Food and Drug Administration
Рет қаралды 12 М.
U.S. Food and Drug Administration
Рет қаралды 7 М.
U.S. Food and Drug Administration
Рет қаралды 3,6 М.
U.S. Food and Drug Administration
Рет қаралды 10 М.
U.S. Food and Drug Administration
Рет қаралды 11 М.
U.S. Food and Drug Administration
Рет қаралды 12 М.
U.S. Food and Drug Administration
Рет қаралды 12 М.
U.S. Food and Drug Administration
Рет қаралды 3 М.